Integrated Management System – A manufactorers perspective

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Contents

1 – What is an integrated management system?

The term “Integrated Management System” (IMS) is used to identify a company’s system built to respond to the requirements of different standards using a single framework.

Often these standards are those of, or based on, ISO standard-families (e.g. 9001, 14001, 50001, 22000, etc..), but it could be also a mixture of different standards, including those non-certifiable (e.g. ISO 9004) or even internal ones (e.g. Compliance).

Having an IMS means that when establishing (or, more rarely, changing) the company’s management system, it is decided to have common organisational elements (structure, roles, responsibilities, resources), policies, objectives and processes to achieve those objectives that cover all the standards in single entities.

The opposite paradigm is what is sometimes called the “Silos” approach, in which certification / compliance with each standard is realised within separated systems with different policies, objectives and processes and organisational elements.
In some cases the organisational elements can be shared among the systems, if the available resources compared with the needed effort needed by the MS allows for it.
Even in the case though, these shared organisational elements will need to be specifically identified in each MS, effectively having to carry “multiple labels” or “multiple hats” to identify the fact that they are used by different MS.

2 – Why having an integrated management system?

Figure 1: Comparison of the EASA regulations structure for design and production organisations (Status Oct-2021). Similar structures…

Figure 2: … very different implementations. Here the different approach between the design domain (high level functional requirements for the QMS as DAS) and the production domain (very prescriptive list of what the QMS . or QS – should contain as procedure) appears evident

Usually the decision whether to have an IMS or a silos-MS is taken by top management, as this has a profound impact on the company “character”, its culture, the way of conducting operations and the amount and kind of resources needed for the maintenance of the management system(s) itself (themselves).

The natural sparring partner for top management in order to drive this decision are cross-functional managers, such as a Quality Manager, a Program Manager or senior technical staff that possibly coordinate multiple activities (for example the head of airworthiness in a DOA that is approaching the stage of setting up a POA as well).

The idea behind pursuing an IMS is that, even with their diversities, the various standards:

  1. Have a common core or set-of-principles that can be abstracted from the special focus of the individual management system (such as quality, environment, energy, etc…) – nowadays this is particularly emphasized with the adoption of the so called “High Level Structure” in the ISO standards. Within EASA Regulations, particularly for domains under the same implementing rules, parallels are evident as well (see paragraph numbers of DOA vs. POA in Figure 1).
  2. Even when the common core is not self-evident, modern standards are all process based and there are certain methods that can be applied to all of them (e.g. audits is a means very often used when it is wished to get insight on the functioning of a process, a product or a service, regardless of the scope of the management system; there will be therefore 2 audit programs, for example).
  3. Because of point 1, part of the requirements, policies and objectives of the standards will overlap; because of point 2, part of the organisation’s elements needed for the functioning of different MS are the same or very similar.
  4. Sometimes the certification-bodies are the same for multiple standards, so a single external authority is actually confronted with different ways of doing things, which can lead to additional request and work to satisfy them.
  5. Suppliers will receive the requirements cascaded down from the various MS. They are normally summarised in an ad-hoc procedure, manual or pamphlet and it is much easier to write it starting from a single IMS rather than from multiple MS.

Considering the points above, the advantages of an IMS approach can be summarized as following:

  1. Redundancies are avoided. Organisational elements shared by the various MS are truly shared, without the need to replicate structures, roles, responsibilities and resources for very similar tasks. This is particularly true for “overhead functions” that are in charge of supporting and management processes.
  2. Potential conflicts are avoided. If the policies, objectives and processes consider all the requirements of the different MS, no conflictual information or execution can arise. Again this is true for both core processes in the added-value chain as well for the supporting and management process.
  3. Additional interfaces that might be needed to synchronise similar tasks split across similar processes belonging to different MS or to aggregate similar data are not needed. Especially for a complex product, this can be a huge saving.
  4. Internal transparency and accountability are enhanced. Fragmentation of responsibility is avoided more easily and there are no “no-one’s-land” portion of the processes, which neither Design nor Manufacturing covers.
  5. Alignment of the company to its objectives is facilitated. The processes can be geared towards them, instead of towards the fulfilment of specific MS-compliance objectives.
  6. The process approach is facilitated at operative basis. Because the Management Systems are defined in terms of requirements, but the reality works in terms of processes, having less processes, less interfaces, less redundancies and less roles makes it lighter to think in terms of customer expectations (1. what is the entity using my output expecting, so that all requirements we are committed to are respected, regardless of from which MS they are coming from? 2. No artificial output to bridge the MS are established in order for example to pass data from one QMS to the other1).
  7. Company knowledge is more shared, staff movements across departments is therefore easier and transfer of specific knowledge of a certain domain can be channelled to improve other domains as well.
  8. Maintaining the IMS costs less (less procedures, less interfaces, less check for potential conflicting and/or repeated information).

The IMS approach has also some disadvantages:

  1. Lower total complexity, but higher barrier to enter, as the IMS setup must consider all disciplines. There is a need for an IMS “architect” and to talk with and listen to multiple entities to define the processes.
  2. Staff recruiting and training more expensive / difficult, starting at medium as the level of awareness of the person involved in all processes must encompass multiple MS’ requirements.
  3. Difficult to implement ”for real“ in large organisations, as different business units and department’s views take precedence over the “generic picture” of the central entity. Lots of consultation with all sites / units are needed to have the buy-in of everybody: this can easily become a large, lengthy effort.
  4. The certification-bodies or authorities for the different parts of the IMS might be different ones, with different legal requirements and background (See Figure 2). Even within the same authority, different staff might be assigned to different portions of the IMS. This poses a challenge as the company must in effect mediate between the requests of the authorities on their behalf and find a common solution.

Figure 3: Unified IMS: a common root for many branches

3 – What does it mean to have an IMS for an aeronautical manufacturer? The unified QMS

Before answering to the question above, it is worth to introduce the concept (actually derived from the ICAO framework) of State of Design and State of Manufacturing.

In aviation the term “State of Design” identifies the country where a manufacturer of a product has its legal entity registered as responsible for the design, i.e. where the R&D (Engineering) is located. This entity is responsible for:

  • the compliance of the product against requirements defined by law;
  • the compliance of the company against requirements defined by law, of which the QMS is an integral part: it is called “Design Assurance System”.

The term “State of Manufacturing” identifies the country where a manufacturer of a product has its legal entity registered as responsible for the manufacturing of the product. This entity is responsible for:

  • the conformity of the product against design requirements within the framework defined by the state of design and the law;
  • the compliance of the company against requirements defined by law (of which the QMS is an integral part: it is called “Quality System”).

Except for particular applications, companies registered within the EU / EEA are bound by law to the EASA as the authority responsible for the State of Design, whereas the single countries can decide which authority is responsible for the state of Manufacturing, generically this being the National Aviation Authority (NAA) of that country; for Germany LBA.

Therefore, even putting aside any other MS that a manufacturer might want to consider (environment, energy, internal compliance, etc..) in effect a manufacturer has always a minimum of 2 set of company requirements to respond to, i.e. those related to the QMS of design and to the QMS of manufacturing.

It is therefore evident that except very few cases, the disadvantage “The certification-bodies or authorities for the different parts of the IMS might be different ones, with different legal requirements and background (See 2). Even within the same authority, different staff might be assigned to different portions of the IMS. This poses a challenge as the company must in effect mediate between the requests of the authorities on their behalf and find a common solution” above is always realised, as the authorities are different by law. A boundary condition that cannot be altered.

Additionally, whereas in the R&D domain the QMS tend to be very customized, within the manufacturing environment (and even more so in maintenance) the NAA tends to expect a standard-structure of the QMS and its documentation, posing an additional challenge to the opportunity for merging with the R&D QMS.
This can be counteracted either with an ad-hoc compliance checklist, or an ad-hoc cross-reference against what the authorities expect to be the standard documentation format of the QMS.

Finally, the language can be a third barrier to the unified QMS; although the EASA would accept any EU language, the NAA often demands (also for legal reasons) the QMS documentation to be in the own State language.
A bilingual approach can be pursued, but it is very resource intensive for the maintenance of QMS.2
Alternatively, one could use the language acceptable to the NAA also for the portion of the QMS responding to the EASA as Design Authority requirements, but this approach proves mostly impractical, due to the very international staff pool mandating de-facto English as the standard language for the R&D and Engineering world.
On the other hand practical experience shows that the NAA can be convinced to use English only at least for those procedures describing processes shared between design and production. A convincing argument has proven to be the evidence that staff acting within this process are active both in R&D and manufacturing (and of course has knowledge of the English language).

After having listed all these challenges, one might ask himself the question: is it really worth pursuing the IMS approach, in spite of all above mentioned difficulties?

4 – The main advantage of a Unified QMS for a manufacturer

The main point for pursuing an IMS is that in fact the manufacturer of an entire product “does not care” chiefly about those distinguishing between design and production imposed by the legal framework. It wants to design, produce and market a product.

As such, its efforts are (or should be) directed in defining objectives policies and processes that are as close as possible as the most sensible realisation of the product, relying on management to find a way to have fast, make-sense, effective, reliable and efficient system, ensuring quality processes and the leanest possible organisational elements.

The “silos” approach is per definition not lean as it does not optimize interfaces and information flow. It also makes it more difficult to use a pull-mechanism vs. a push-mechanism to retrieve information (the end-user of the process output of another MS will normally have difficulties in understanding “where this is coming from” and “why it is done at this time and like this”).

Also a big advantage of the unified QMS is a more “profound” internalisation of the process approach at operative level and common objectives and policies, which foster the customer perspective in the process owners.

Furthermore, whereas a clear separation between R&D and production is evident and easy to realise at QMS and organisational level for a product in series production, this is much more difficult to do in case of new developments (prototypes) or product upgrades / changes3.

Although the EASA rules clearly put the DOA in charge of the prototype, also in terms of manufacturing, it is not advantageous and generically expensive to create a full parallel manufacturing unit detached from the series-manufacturing organisation:

  1. The resources will be duplicated, whereas with a delta-training / adaptation already available resources from the series-manufacturing could do the job as well
  2. The learning effect that can save time and increase quality in series ramp-up needs to be addressed specifically, as it won’t be a natural development transitioning from prototype to series (the resources will be different or would need to be qualified again ad-hoc for the series).
  3. Dedicated processes and iterative steps are still needed, but at least a knowledge transfer can take place also at process level (similar to point 2).

4.1 – One manufacturer but different legal entities

There is another aspect that is worth mentioning and that poses a challenge to the unified QMS approach. It is the decision of some manufacturers to split design, production (and maintenance) in different legal entities; this decision is driven mostly by financial considerations.

A unified QMS is still possible, but a minimum of extra interfaces or contractual stipulations will be needed to respond to all legal requirements. This in turn will hinder the short-term freedom of each organisational unit, which is the normally sought by such arrangements. For example significant changes, shutting down, selling, rebranding or changing scope of one organisation cannot be “just done” without considering the impact on the other ones and entering into a round of discussions with the authorities. In turn this would make the unified QMS unappealing to top management (provided the far-reaching implications of such approach are present to their minds).

If the reason for splitting the entities is bound to have a broader scope of one of them (i.e. being the manufacturer but also a supplier), the unified QMS approach would become virtually impossible and it makes probably more sense to have 2 separated QMS with formal interfaces, that can be generalised for internal and external customers (or to have a company dedicated to be a supplier and still using a unified QMS approach for the manufacturer).

5 – The Engineering Completion Centre: a QMS with provisions for others or integrating systems outside the company?

A particular type of business that offers few extra challenges is the “Engineering completion centre” type of activity, i.e. a DOA without its own production that design ad-hoc refurbishment / upgrade / modification of aircraft and/or its systems (e.g. new cabin interior, integration of special mission equipment, etc).

In this case the DOA will need to partner with a POA for the production of parts and also with an MRO (required in this case as the installation happens on an already certificated products) to offer to the customer the required change “ready-to-fly”.

The situation might get even more complicated when the customer is heavily involved in the drafting of the specification, sometimes even deciding where to buy not only the equipment, but also “the production service” and even when and where to perform the installation on the aircraft (typically coupled with some sort of heavy maintenance that the aircraft must do, for which the MRO partner is fixed, in order to use the forced down-time of the machine in some kind of “productive way”).

This situation is extremely challenging for the company in charge of the design and certification, as it is responsible for the final certification and completion of the aircraft (we are talking here of “one-off”s, not series)

The design & development QMS (the DAS) will have provisions for interfaces with production, as they are mandated by the regulations (21.A.4) but will have also provisions for interacting with the MRO, something that an aircraft manufacturer does not need when building new machines. EASA published in 2012 the “Good Practices” document EASA_S21_GP001, which offers a very solid base upon which build the processes for the interfaces with the MRO, including data exchange (like for the POA), MROs supply chain management and definition of roles, responsibilities and authorities during the installation, its verification, conformity, testing, and final release to the customer.4

Although from a QM-professional perspective it is probably tempting to provide “provisions for” the other QMS to interact with the DOA QMS by putting in place a series of processes and just reference these in Quality Arrangements with the POA and the MRO, my personal experience (circa 15 projects with 4 different partners) is that it is very difficult to do that, as each company uses different terminology, has different roles (or lack thereof) and it is used to get inputs in different ways (especially when their size is small, the way of working is very much NOT standardised).

Therefore my personal recommendation would be to invest the time and effort in creating dedicated process(es) under the DOA QMS umbrella, tailored and drafted together with QM/PM of the other 2 companies (POA and MRO): this can save tons of misunderstanding and “responsibility ping-pong” down the line, especially as sometimes these POA and MRO have a total different perspective on the aviation regulations and are not even aware of the obligations and privileges that a DOA has. A personal rule of thumb that I use is that if there are more than 3 projects planned with these partners and/or the planned effort is longer than 6 months, it is definitely worth (and generally easy to sell to your own MD and the PM controlling the project) investing 40 hours to draft this process with the other 2 companies.

As a final remark, in my experience such kind of business (one-offs) is very difficult to be significantly remunerative as the lack of scaling in the projects does not allow to compensate for the many hiccups (costing additional time and money) that inevitably are connected to a first prototype installation.
If your company is thinking of entering this business, talk to your MD about the points above, if you can 😊.

6 – IMS by choosing another standard as a “wrapper”

A variant of the Unified QMS approach can be the choice of another more neutral standard (typically EN9100 or ISO9001) under whose umbrella other QMS will be linked. Although the full advantages of an integrated system are not leveraged in this way, the QMS global umbrella will allow at least to visualize and standardise the interfaces, getting a global picture of the company processes, that can be used to steer and change the management systems.

Nonetheless, because the additional umbrella standard requires extra effort (and costs, including those to reach and maintain certification), it appears to me as an additional layer of complexity that does not completely pays off in terms of gained effectivity and efficiency. In my opinion it is an approach not worth pursuing, except as a middle step in the direction of a unified QMS, for example when operating on an already existing structure, as when various companies are bought from the same entity and subsequently merged or integrated.

7 – Conclusions

I presented in these pages some personal considerations and solutions that I have experimented in the past 15 years in the aeronautical business. Whenever I advocated for a specific solution rather than another I tried to present the rationale that convinces me that this is the “right” solution.

Personally, I am in favour of unifying the QMS as much as possible. It increases the planning effort (higher medium complexity), but scales and adapts better with changing needs, making execution in the long term easier. As it is often the case, the argument is that planning more will pay off later, although in my experience it is difficult to convince MDs (and sometimes unfortunately also PMs!) to invest the time upfront 😊.

These conclusions though are not drawn scientifically and the data I have is scarce.
If there is interest in the QM-community, we can try to design a poll to collect data regarding this aspect and publish it as an attachment to this article.
Also I would be very thankful for ideas or statements and examples, especially if contrary to my conclusions here, so that we can offer an even more complete picture of the topic.

1 The main example is the need (or lack of) DO-PO arrangement to pass data between DO and PO. By 2 formally separated QMS, the natural way would be to have a DO-PO arrangement and output would be generated to transfer data and requests from the DO to the PO and vice versa, although the entity is the same one!

2 Data from a single example show almost a triple effort for drafting and checking of QMS-documentation for a bilingual system.

3 Of course under the assumption that the R&D project is meant to enter series production from the beginning. For pure study projects, never leaving the prototype status or extremely small series (1-4 units) the entire manufacturing QMS is basically not needed.

4 Special attention to be given in describing how the aircraft gets from the MRO/CAMO QMS to the DOA QMS and finally back into the MRO/CAMO QMS to receive ist final release to service fort he customer It is critical that it is clear at all time of the process